Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02474550

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

41.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL) treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will prospectively collect clinical data and treatment outcome of patients with DLBCL who use prophylactic pegylated-filgrastim.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma Neutropenia, Febrile

Detailed Description

Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy
Prphylactic peg-filgrastim on the day after chemotherapy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
CISL 14-03 Patients who were newly diagnosed with Diffuse Large B cell Lymphoma (DLBCL). Aged 19 or more Treated with R-CHOP therapy

Outcome Measures

Primary Outcome Measures

incidence of febrile neutropenia [within 30 days]

Secondary Outcome Measures

incidence of chemotherapy-related adverse events other than febrile neutropenia [4 weeks after completion of chemotherapy]
Overall survival [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

19 or older
newly diagnosed with DLBCL
R-CHOP chemotherapy
offer informed consent

Exclusion Criteria:

other subtype of NHL
concomitant other cancer
previous chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou Universtiy School of Medicine	Suwon	Kyeonggi	Korea, Republic of	443-721
2	Soon Chun Yang University Hospital Bucheon	Bucheon		Korea, Republic of
3	Busan Paik Hospital	Busan		Korea, Republic of
4	Chungbuk National University Hospital	Cheongju		Korea, Republic of
5	Keimyung Univerisity Dongsan Medical Center	Daegu		Korea, Republic of
6	Yeungnam University Hospital	Daegu		Korea, Republic of
7	Chungnam National University Hospital	Daejeon		Korea, Republic of
8	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
9	Gachon University Gill Hospital	Incheon		Korea, Republic of
10	Chonbuk Nationa University Hospital	Jeonju		Korea, Republic of
11	Gyeongsang National University Hospital	Jinju		Korea, Republic of
12	Asan Medical Center	Seoul		Korea, Republic of
13	Choong Ang University Hopspital	Seoul		Korea, Republic of
14	Hallym University Sacred Heart Hospital	Seoul		Korea, Republic of
15	Hanyang University Hospital	Seoul		Korea, Republic of
16	Hanyang University Medical Center	Seoul		Korea, Republic of
17	Inje University Sanggye Paik Hospital	Seoul		Korea, Republic of
18	Korea Cancer Center Hospital	Seoul		Korea, Republic of
19	Korea Institute of Radiological & Medical Science	Seoul		Korea, Republic of
20	Korea University Anam Hospital	Seoul		Korea, Republic of
21	Samsung Medical Center	Seoul		Korea, Republic of
22	Seoul National University Hospital	Seoul		Korea, Republic of
23	Ulsan University Hospital	Ulsan		Korea, Republic of
24	Wonju Severance Christian Hospital	Wonju		Korea, Republic of